The present invention relates to the field of surgery, and more particularly to an apparatus and method for surgical treatment of female urinary stress incontinence.
Stress-induced urinary incontinence (SUI) may be caused by a variety of activities, such as coughing, laughing, sneezing, exercising, lifting of heavy objects and other everyday activities. Sudden change of pressure in the intra-abdominal cavity causes the urethra to incompletely shut and leakage occurs. Such phenomenon usually takes place when there is an insufficient support of the urethra from the pelvic floor muscles and the structures within the muscles. A number of factors cause this effect: aging, vaginal deliveries of babies, changes in hormonal level, and others.
The present invention takes into consideration the fact that women suffering from the SUI show deficient levels of collagen in the matrix of the tissue that supports the urethra and the base of the bladder, the bladder neck. The supporting tissue resembles a trampoline that stretches underneath the bladder; when the support is weakened or sagging, the entire pelvic floor experiences changes that may lead to SUI, vaginal prolapse and other diseases.
Conventionally, SUI is treated with medications, injections or surgically. Most available medications have undesirable side effects, which limits their use. Some physicians recommend exercises to strengthen pelvic floor muscles. However, these exercises must be followed upon daily, otherwise their effectiveness is considerably reduced.
Some physicians use collagen injections into the urethra or bladder neck to cause coaptation of the urethra. Such injections are relatively expensive; the injection cycles must be repeated three or four times in a 12- or 18-month period and the success rate is about 70 percent at most. The injected collagen is metabolized, it migrates, or spreads into the surrounding tissue, and the desired bulking of the tissue almost disappears. Consequently, the injections must be repeated sometimes every six months, which further increases the cost of this type of treatment. Additionally, since the treatment usually involves injections of bovine collagen, the issue of mad cow disease takes another dimension.
Surgical procedures use a technique called the Pubo-Vaginal Sling. A strip of the patient""s tissue, or a donor tissue, or a synthetic graft is surgically implanted around the urethra to strengthen the pelvic floor. Some of the strongest materials available, Pelvicol, is a homogenized collagen matrix made from pig""s skin. The sling is implanted through the vagina, sometimes avoiding the need for an abdominal incision. As in many other surgical procedures, the skill of the operating physician is extremely important. If the sling is tensioned too tightly, it may interfere with the patient""s urination, or the patients develop an overactive bladderxe2x80x94frequent involuntary contractions of the bladder. If the sling is too loosexe2x80x94the desired support has not been achieved.
A more recent procedure was suggested that involves application of radio frequency (RF) to the pelvic floor through the vagina. The theory behind this procedure is denaturing of collagen of the tissue surrounding the bladder by high frequency radio waves. It is expected that the denatured collagen will then recoil and tighten up the muscles. At this present time, this technology can only be achieved by first making a vaginal mucosal incision with mobilization of the vaginal mucosa off the underlying pelvic floor supporting matrix.
The present invention contemplates elimination of drawbacks associated with the prior art and provision of an apparatus and method for treating female stress urinary incontinence without having to incise the abdominal cavity or the vaginal mucosa.
It is, therefore, an object of the present invention to provide an apparatus for treating stress-induced urinary incontinence in women.
It is another object of the present invention to provide an apparatus for tightening pelvic floor muscles that support the bladder by denaturing collagen of the tissue and causing the tissue to recoil.
It is a further object of the present invention to provide a method of treating stress-induced urinary incontinence that does not require incision through the abdominal wall or vaginal mucosa.
It is still another object of the present invention to provide a method of treating stress-induced urinary incontinence that is minimally invasive.
These and other objects of the present invention are achieved through a provision of an apparatus for treating female stress-induced urinary incontinence and other similar diseases associated with weakening of the pelvic floor muscles. The apparatus of the present invention has a vagina probe member provided with a laser output in a forward portion thereof. The laser output is operationally connected to a medical laser generating and monitoring device that delivers a transmucosal laser beam to selected areas in the pelvic floor.
A temperature-conductive cover forms a portion of the probe member adjacent the laser output. A cooling medium is circulated behind the cover to cool the temperature of the tissue immediately surrounding the operation site (vaginal mucosa) where the laser beam is directed. The cooling medium, such as water, is supplied by a circulation pump operationally connected to the probe member through a suitable conduit attached to the handle of the probe member.
A guiding catheter with one or more temperature sensors is provided with an inflatable balloon adjacent to the forward end thereof. The guiding catheter is sized and shaped for positioning in urethra of the patient. When the catheter end reaches approximately the desired location, the balloon is inflated and a surgeon pulls slightly on the handle of the catheter to force the balloon to sit in the neck of the bladder. The catheter is provided with a measuring indicia on an exterior surface thereof to facilitate determination of the distance between the external meatus and the bladder neck.
The probe member is likewise provided with measuring indicia on the external surface thereof. Before the laser is activated, the surgeon notes the distance to the bladder neck to make sure that the laser output is at a level corresponding to the bladder neck.
The temperature sensors of the guiding catheter send a continuous signal to a temperature monitoring device and to the laser activation device. If the temperature inside the urethra exceeds the allowed pre-selected level, the monitoring device de-activates the laser and terminates the supply of energy to the probe member.
The tissue collagen of the selected areas affected by the laser energy denatures and recoils, causing tightening of the pelvic floor muscles, especially muscles surrounding the urethra. As a result, the stress-induced incontinence of the patient is minimized or even altogether eliminated.